Cambridge Healthtech Institute’s Eight Annual
Protein Aggregation and Stability in Biopharmaceuticals
Analytic, Formulation, Manufacturing and Regulatory Challenges
Part of the 11th Annual PEGS: the essential protein engineering summit
May 7-8, 2015 | World Trade Center | Boston, Massachusetts


The phenomena of protein aggregation is a complex conundrum that impacts biopharmaceutical development at virtually every stage. All mechanisms of aggregation are not conclusively known, but the industry must use every effort to characterize and control this condition – and to reflect these efforts in regulatory filings. A changing landscape of assays, instrumentation and processes support the need to collect, analyze and report this data. Requirements for understanding the correlation between aggregates and immunogenicity shape analytical and clinical studies. In addition, aggregation resulting from new higher concentration protein formulations yields new challenges in drug product development, delivery systems and manufacturing processes. The PEGS Protein Aggregation and Stability in Biopharmaceutical Products meeting offers important scientific updates and a forum for dialog among the stakeholders in this challenging arena.

PREDICTING AND CHARACTERIZING THE MECHANISMS OF AGGREGATION  

KEYNOTE PRESENTATION: New Aggregation Properties of Therapeutic Proteins Revealed by New Analytical Methods

Tudor Arvinte, Ph.D., Professor, Biopharmaceutics, University of Geneva; CEO, Therapeomic, Inc.

Predicting Agitation-Induced Aggregation Propensity of Monoclonal Antibodies

Ankit Patel, Ph.D., Scientist, Genentech

Predicting Aggregation-Prone Sequences in Proteins

Joost Schymkowitz, Ph.D., Principal Investigator, VIB Switch Lab, KULeuven, University of Leuven, Belgium

FORMULATION AND PROCESS STRATEGIES TO CONTROL PROTEIN AGGREGATION 

Predicting Protein Aggregation during Storage in Lyophilized Solids Using a Combination of Biophysical Analyses

Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Industrial and Physical Pharmacy, Purdue University

Thermal Unfolding and Aggregation of Human IgG1 Fc Fragment: the Relevance of Solution Composition

Jifeng Zhang, Ph.D., Head, Drug Product Analytics and Characterization, Drug Delivery and Delivery Development, MedImmune

Formulation Strategies to Control Protein Aggregation

Patrick Garidel, Ph.D., Associate Director, Protein Science, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

The Effect of Resin Pore Size, Particle Diameter, and Ionic Capacity on the Resolution of Monoclonal Antibody Monomer from Aggregate During Preparative Cation Exchange Chromatography

Benj Guzman, Senior Associate Scientist, Purification Process Development, Amgen

Targeted Mutagenesis of a Therapeutic Human Monoclonal IgG1 Antibody Prevents Gelation at High Concentrations

Paul Casaz, Ph.D., Research Scientist, University of Massachusetts Medical School

Purification Strategies to Control Protein Aggregation

Raja Ghosh, Ph.D., Professor, Canada Research Chair in Bioseparations Engineering, McMaster University, Canada

DEVELOPABILITY EVALUATION AND OPTIMIZATION 

Defining Antibody Developability Rule of Thumb by Its Self- and Cross-Interactions Yingda Xu, Ph.D., Associate Director, Protein Analytics, Adimab

Anion-Protein Interactions and Relevance to Solution Properties and Stability

Peter Ihnat, Ph.D., Principal Research Scientist, Drug Product Development Pre-Formulation, AbbVie

Mutational Approaches to Improve the Biophysical Properties of Human Single-Domain Antibodies

Jamshid Tanha, Ph.D., Research Officer, National Research Council, Canada

Concentration Dependent Viscosity of Monoclonal Antibody Solutions: Explaining Experimental Behavior in Terms of Molecular Properties

Li Li, Ph.D., Research Scientist, Pfizer, Inc.

PEG-Induced Liquid-Liquid Phase Separation in Protein Solutions

Ying Wang, Ph.D., Research Associate, Physics and Biological Physics, Massachusetts Institute of Technology